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Associate Scientist - Cell Culture

Posted on Apr 5, 2021 by AstraZeneca

Gaithersburg, MD 20877
Immediate Start
Annual Salary

Summary of the group:

The Development Scale Up Center (DSC) at AstraZeneca in the Manufacturing Sciences department (within Research and Development) is responsible for process scale up, technology transfer, and facility fit assessment of clinical and commercial processes to the DSC. The Associate Scientist will be responsible for the scale-up of cell culture and fermentation development batches that produce material for toxicology studies, process lock and early/late-stage development and to meet material demands to support CMC teams. The data generated from the DSC is used to determine facility fit and assist with the tech transfer of the manufacturing process to internal and external cGMP facilities. The candidate will perform cell culture and fermentation operations, including CIP/SIP, sampling, data analysis, and harvest operations to produce drug substance at pilot-scale (100L to 1,000L). The DSC, in collaboration with cell culture and purification development scientists and process engineers within R&D, also evaluate innovative technologies, implement novel process control/automation methods and support scale down model development. The environment is fast-paced, challenging and dynamic, with varying degrees of process definition and frequent piloting of novel process operations and novel molecule formats.

Main Duties & Responsibilities:

This position is focused on the production of therapeutic proteins in Development, Process Scale-up. Responsibilities include preparing media solutions and executing cell culture and harvest operations (single-use bioreactors and stainless steel bioreactors, continuous centrifugation, depth filtration, membrane filtration) with pilot scale equipment and systems.

This role will also require the following:

Preparation of stock solutions/media, excellent aseptic technique, operation and maintenance of blood-gas analyzers, automated cell counters, bioreactors and continuous centrifuges.
Technology transfer and execution of cell culture and fermentation processes for various molecules. Transfer data to support large scale manufacturing and the ability to investigate/troubleshoot operational issues.
Maintain chemical and lab supplies inventory and requests vendor quotes as needed.
Good organization and interpersonal skills with the ability to interact effectively with CMC team members, project teams, manufacturing personnel, and suppliers is essential.
Makes detailed observations, analyzes data, and interprets results
Evaluate new technologies and implements new tools to improve process outcomes.
Education & Experience Requirements:

Chemical engineering or engineering discipline is preferred, however candidates with biochemistry, chemistry, biology or related fields will be considered.

Associate Scientist I: Bachelor's degree with 5-8 years or a Master's degree with 2-5 years of related experience in industry or academia.

Associate Scientist II: Bachelor's degree with 9+ years or Master's degree with 6+ years of related experience in industry or academia.

Required Skills:

Experience operating cell culture and fermentation equipment; rocker motion and stirred tank bioreactors, CIP/SIP of stainless steel tanks/bioreactors, understanding of bioreactor control systems, offline analytics, and must have excellent aseptic technique.
Proficient with Excel, Word, PowerPoint, and data analysis.
Able to communicate and present data to scientists, engineers, and management.
Familiarity with root cause analysis and problem-solving tools.
Position requires periodic weekend work and evening shifts
Desired Skills:

Knowledge of engineering principles including mass transfer and heat transfer
Experience in operating large scale bioreactors (>50L scale).
Fundamental understanding of important quality attributes necessary for cell culture and fermentation

Reference: 1152694735

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